1. Field of the Invention
The invention is directed to surgical devices. More specifically the invention is directed to gastric surgical devices such as bougies or dilators with improved location and placement ability.
2. Description of Related Art
Obesity is a common and growing problem in the United States and the rest of the world. Owing to poor diet, unthoughtful community planning that de-emphasizes walking and outdoor spaces, and plenty of sedentary distractions, people are becoming fatter in epidemic proportions.
One vector to combat the obesity epidemic is bariatric or weight loss surgery. During such surgery in general, portions of the gastrointestinal tract are either removed, bypassed, or constricted to prevent excessive amounts of food from being ingested by the patient afterwards. Weight loss is extremely common thereafter.
During gastric sleeve resections for weight loss (vertical sleeve gastrectomy, VSG) and other operations involving the esophagus and stomach, there is a need for placement of a bougie/dilator, a slender, flexible, hollow or solid, cylindrical instrument for introduction into a tubular organ, usually for calibrating or dilating constricted areas. The bougie is placed down via the mouth and across the esophagus and/or stomach or small bowel. The purpose of this device is to act to dilate strictures and/or help delineate the borders of the stomach/esophagus for resection. Standard sizes include 34 French to 40 French but a myriad of diameters can at times be needed. The bougie/dilator can have a blunt tip or a tapered tip and can be wire guided or placed blindly. The device can be constructed out of any biocompatible material such as medical grade plastic silicon or similar material which has the appropriate degree of rigidness and flexibility to accomplish this purpose.
During placement of the bougie/dilator there is a vital need to know and identify the location of the distal-most aspect of the dilator tip. In the case of a VSG procedure the bougie dilator must be maintained in the proper position throughout to ensure adequate diameter of the sleeve. A sleeve made too small by, for example, slippage of the bougie out of place can be devastating causing gastric obstruction sepsis and death. Since the bougie/dilator is contained within the lumen of the stomach and the wall of this organ is opaque there is a need for some method to identify the location of the tip and thereby ensure that it has not slipped back or moved.
In addition, there are other gastric surgical procedures that currently employ a bougie. For example, when a patient has a naturally occurring improper gastric constriction or obstruction, a bougie may be employed to dilate the constriction or open the obstruction. In these cases as well, knowledge of the precise location of the bougie, especially the tip of the bougie, with respect to the anatomy of the patient, is highly desirable.